Bioequivalence and Bioavailability Forum

Pseudo-validation [R for BE/BA]

we had already a couple of times the discussion whether R can be used in regulated environments, and the answer was always: Yes – if the code is validated.

When it comes to the package PowerTOST, in the /tests sub-folder of the library you find scripts which you can use to black-box validate your installation, i.e., compare the results with the respective reference tables.
If you are an expeRt, you can inspect the code for correctness (white-box validation). Given, pretty difficult.

Another approach is to perform simulations, like in ElMaestro’s famous EFG.
I started with sample sizes for ABE.